Stem definition | Drug id | CAS RN |
---|---|---|
blood coagulation factors | 5178 | 1270012-79-7 |
Molecule | Description |
---|---|
Synonyms:
|
consists of factor VIII fused to the Fc domain of IgG1; for treatment of hemophilia A
|
None
None
Date | Agency | Company | Orphan |
---|---|---|---|
Nov. 19, 2015 | EMA | Swedish Orphan Biovitrum AB |
None
MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
---|---|---|---|---|---|---|
Haemorrhage | 1080.41 | 75.60 | 256 | 821 | 51114 | 34904740 |
Factor VIII inhibition | 234.73 | 75.60 | 33 | 1044 | 293 | 34955561 |
Traumatic haemorrhage | 227.36 | 75.60 | 36 | 1041 | 755 | 34955099 |
Haemarthrosis | 200.35 | 75.60 | 40 | 1037 | 3219 | 34952635 |
Spontaneous haemorrhage | 195.02 | 75.60 | 28 | 1049 | 292 | 34955562 |
Limb injury | 126.11 | 75.60 | 35 | 1042 | 11654 | 34944200 |
Joint injury | 124.87 | 75.60 | 33 | 1044 | 9140 | 34946714 |
Muscle haemorrhage | 88.76 | 75.60 | 21 | 1056 | 3697 | 34952157 |
MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
---|---|---|---|---|---|---|
Haemorrhage | 992.37 | 83.91 | 221 | 693 | 90897 | 79652577 |
Traumatic haemorrhage | 228.72 | 83.91 | 34 | 880 | 1299 | 79742175 |
Factor VIII inhibition | 185.88 | 83.91 | 24 | 890 | 314 | 79743160 |
Haemarthrosis | 184.99 | 83.91 | 35 | 879 | 5777 | 79737697 |
Spontaneous haemorrhage | 164.70 | 83.91 | 24 | 890 | 793 | 79742681 |
Limb injury | 123.70 | 83.91 | 34 | 880 | 29494 | 79713980 |
Joint injury | 112.59 | 83.91 | 32 | 882 | 31303 | 79712171 |
Muscle haemorrhage | 98.44 | 83.91 | 21 | 893 | 6279 | 79737195 |
None
None
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Hereditary factor VIII deficiency disease | indication | 28293008 | DOID:12134 |
None
None
None
None
None
None
ID | Source |
---|---|
7PCM518YLR | UNII |
C3834170 | UMLSCUI |
CHEMBL4297945 | ChEMBL_ID |
D10539 | KEGG_DRUG |
DB11607 | DRUGBANK_ID |
9680 | INN_ID |
C587014 | MESH_SUPPLEMENTAL_RECORD_UI |
1543089 | RXNORM |
30674 | MMSL |
015552 | NDDF |
718943005 | SNOMEDCT_US |
781174009 | SNOMEDCT_US |
None